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AI-Driven TLF Validation

Transforming clinical reporting with intelligent automation for accuracy, efficiency and regulatory compliance.

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Key features

Checks that usually wait for manual QC, done automatically

Layout & formatting

  • Page margins, borders, fonts and alignment
  • Pagination and blank page checks

Titles, headers & footnotes

  • Title and analysis set validation
  • Footnote completeness, numbering and symbols
  • Treatment group and period labels

Shell compliance

  • Required and excluded rows
  • Parameter ordering and sorting rules
  • β€œNot coded” category handling

Data & statistical consistency

  • Subject counts vs ADaM datasets
  • Percentages, denominators and decimal precision
  • Min/Max, P90 and descriptive block validation

Cross-table validation

  • Alignment across efficacy and safety tables
  • Detection of repeated or missing summaries

Intelligent validation

The tool understands shell intent, detecting issues that normally appear only during late-stage manual QC.

Measured impact

Faster timelines without compromising quality

  • Significant reduction in manual validation effort
  • Fewer repeat QC comments
  • Earlier detection of critical issues
  • Consistent and accurate outputs
Lessmanual validation effort, with every check automated
1st runcleaner outputs, fewer review cycles
Who benefits

Built for every team that reviews TLFs

Biotech & pharma sponsors

Faster submissions, reduced operational risk and better oversight of outsourced deliverables.

CROs

Increased throughput without additional headcount, with consistent quality across studies.

Biometrics & statistics teams

Less time on repetitive checks and more focus on scientific review and complex derivations.

Inspection-ready by design

Traceable, repeatable and validated outputs support regulatory inspections and audits, giving you confidence in submission readiness.

Measured impact of AI TLF validation
Client Trust & Recognition

Sponsors and partners report

  • Cleaner first-run outputs
  • Fewer review cycles
  • Standardized quality across studies and programs
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Automation calculator

See how much QC time automation can save you

Move the sliders to match your studies. Your estimate updates instantly.

Your QC workload

Tell us roughly how you work today.

Your estimated savings

Per year, with AI TLF QC automation

0QC hours saved / year
$0Estimated cost saved / year
0Working weeks freed
Manual QC
0 h
With AI TLF QC
0 h

Indicative estimate based on our typical 40–60% reduction in QC effort. Actual results depend on your outputs, standards and processes.

Book a live demo β†’
We will email your estimate and may follow up once. See our Privacy Policy.
Book a live demo

See AI TLF QC check your outputs in 30–45 minutes

We will walk you through the tool on sample tables, listings and figures, and show how it fits into your current QC process.

  • Layout, titles, footnotes and shell compliance checks
  • Subject counts and statistics checked against ADaM
  • Cross-table consistency and version comparison
  • Audit-trail ready validation logs

Prefer email? Write to info@sigma-chiconsulting.com.

Request your demo

We reply within one business day.

Let’s Shape the Future of Your Clinical Studies Together

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